Konnekt will be managing all recruitment for Torrent Pharma Malta exclusively.
Torrent Pharma Malta, a start-up company focusing on Pharmaceuticals and batch release testing is looking for a Microbiologist. The responsibilities include:
- Managing the Microbiology Laboratory Team within the Quality Control Department and ensuring that team members are focused on achieving company objectives in accordance with the company’s quality system and EU GMP.
- Coordinating and Performing daily laboratory operations and address or escalate any emerging issues, as required.
- Training and Developing Microbiology Laboratory Team members, as needed, to ensure continued compliance with required regulatory standards.
- Assigning testing / QC activities to Microbiology Laboratory Team members.
- Preparing and Reviewing standard operating procedures, method validation protocols and reports pertaining to Microbiology Laboratory activities/equipment.
- Ensuring that environmental testing on the Microbiology Clean rooms is done in accordance with the Validation Master Plan (VMP) and all parameters are in control.
- Monitoring and Coordinating analysis of Purified Water according to Company procedures.
- Monitoring the handling of equipment and ensure that this is done in the proper manner and not in a way which may be detrimental to its function.
- Performing / Delegating / Overseeing the Microbiology Laboratory equipment qualification and calibration according to a predetermined schedule.
- Assisting external contractors in performing qualification/calibration of equipment within the Microbiology Laboratory and keep records of these according to Company procedures as required.
- Working out / Assisting in calculations pertaining to microbiological analysis and produce the relevant documentation in association always in compliance with EU GMP.
- Supporting the Company’s Continuous Improvement Strategy, with the scope of achieving operational excellence. Implementing Lean Initiatives and Kaizen events will serve as a basis for continuous improvement.
- Communicating routinely and effectively expectations and deliverables in line with key performance indicators (KPIs).
- Maintaining, Retaining and Archiving Quality Control documentation in line with company policies and procedures.
- Ensuring that appropriate equipment/software validation, qualification and/or calibration have been performed in accordance with the Validation Master Plan (VMP).
- Monitoring and ensuring that the testing environment in the Quality Control Laboratory is controlled at all times.
- Maintaining Quality logs and registers as dictated by the relevant Quality Control procedures.
- Approving finished product testing results against approved analytical methods and specifications.
- Ensuring that all Quality Control procedures and documentation are up-to-date and within their expiry date and instigate their revision if necessary.
- Participating in the initiation and follow-up of change controls, as required.
- Participating in the initiation and investigation of deviations, as required.
- Assisting in the handling of market complaints and in investigations as required.
- Participating in self-inspection activities and provide any required documentation accordingly.
- Assisting in the preparation for incoming regulatory and client audits, and represent the company during such audits, as required.
- Participating in external supplier audits, as required.
- Preparing appropriate documentation and evaluate analytical trends related to Quality Management reviews.
- Reporting and investigating OOS results in a timely manner.
- Assisting the Quality Control Manager in Quality Investigations.
- Carrying out other Quality Control related duties as may be required.
All candidates are to be well-versed in EUGMP with special focus on laboratory data integrity and compliance.
Candidates will be subject to psychometric testing prior to the undertaking of employment.
Working hours 0700am to 1530hrs.
Employment commencement date February 2024.
Skill-sets and Requirements
- Minimum of five-years’ experience and two years team management experience in an EUGMP microbiology laboratory with progressive levels of responsibility.
- Expert in pharmaceutical microbiology testing and related equipment/instruments.
- Familiar with the Ph Eur and cGMP/EU GMP regulations and guidelines.
- Experience with microbial contamination control of aseptic process.
Education & Experience
Bachelor’s degree or above in Microbiology or Biotechnology related scientific discipline.
Job Reference: KK027
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